Competitive Generic Therapies | Guideline Explorer

Description

The FDA Reauthorization Act of 2017, or FDARA, created a pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT.

Scope & Applicability

Product Classes

5

Competitive Generic Therapy

A drug designated with inadequate generic competition; Drug designated as CGT due to inadequate generic competition; Drugs designated under section 506H with inadequate generic competition

RLD

Reference Listed Drug used as the basis for an ANDA submission.

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Reference Listed Drug

The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences

Competitive Generic Therapies

designated as CGT prior to the GDUFA goal date

Stakeholders

2

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

first approved applicant

ANDA applicant eligible for CGT exclusivity; The applicant eligible for CGT exclusivity

Regulatory Context

Attributes

6

Inadequate generic competition

Criteria for designating a drug as a CGT

75-day period

Timeframe to commence marketing to avoid forfeiture

75 calendar days

Timeframe to market drug after ANDA approval to avoid forfeiture

GDUFA goal date

CGT designation does not result in a shorter GDUFA goal date

180-day patent challenge exclusivity

Exclusivity for first applicant filing a paragraph IV certification

CGT exclusivity

New 180-day exclusivity created by FDARA for competitive generic therapies

Related CFR Sections (7)

21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.
(a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →
21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →
21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
21CFR314.93§ 314.93 Petition to request a change from a listed drug.
(a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →
21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →